Mergers & Acquisition is a term that refers to two similar although different topics. Mergers are when two entities, comparable in size, combine ("merge") together, resulting in a new entity. On the other hand, Acquisition is when...
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Marco Polisena
Good Documentation Practices in Regulated Environments
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you did a poor job no matter what you really did." —Marco Polisena Introduction Good Documentation Practices (GDP) has...
Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the...
Manual vs. Automated Testing
“I don't care if it works on your machine! We are not shipping your machine!” — Vidiu Platon. Introduction Whether we are considering testing related to Software / IT environment, we can distinguish two kinds of testing...
